The AMAS test measures serum levels of AMA, an antibody found to be elevated in most patients with a wide range of active non-terminal malignancies.
AMA is the antibody to Malignin, a 10,000 Dalton polypeptide which has been found to be present in most malignant cells regardless of cell type or location (refs.1 to 8). Unlike tests such as CEA , which measure less well-defined antigens whose serum levels tend to be inconstant but elevated late in the disease, the AMAS test measures a well-defined antibody whose serum levels rise early in the course of the disease. In some cases, the AMAS test has been positive (elevated) early , i.e. 1 to 19 months before clinical detection.
All of the data, from both Bogoch et al. (ref.4) and from the independent study performed by SmithKline Laboratories(ref.6) support the fact that the AMA (Anti-Malignin Antibody) is elevated almost regardless of the site or cell type of the malignancy; that is, AMA is a general transformation antibody, not just for one particular kind of cancer. For sera shipped overnight, false positives are 5% and false negatives 7% (3,315 double-blind tests of patients and controls, (refs.4, 6 and 8).
Anti-Malignin Antibody is elevated in 93-100% of cases in which active non-terminal malignancy is the clinico-pathological diagnosis; overall asymptomatic (’false’) positives are 5% in sera kept shipped overnight (refs.4-8). AMA is normal in 96% of cancer patients who no longer have evidence of disease (refs.4,6). Within-run, inter-technician-same-lab, and inter-lab variability are low, as reported in the Smith-Kline study(ref.6).
Every AMAS test is run under rigorous quality control. Control solutions containing known amounts ofstandard monoclonal AMA are run with each test. AMA, when produced in vivo as mouse (ref.3) or as human (ref.7) immunoglobulin, and when isolated from human serum (ref.7) is predominantly IgM. Target® reagent shelf life is as long as 7 years. |
